Improving Access to Maternal, Newborn, and Child Health Medical Products in Low- and Middle-Income Countries: Considerations for Effective Registration Systems

In low- and middle-income countries (LMICs), access to lifesaving maternal, newborn, and child health (MNCH) medical products is not just a supply chain issue. Challenges in the registration process limit the availability of lifesaving quality-assured MNCH medical products, including medicines, medical devices like oxygen concentrators and pulse oximeters, and medical gases such as oxygen. As a result, medical products may be slow to enter the markets where they are needed the most and quality-assured products, including those in WHO’s prequalified list, are not registered or their registration status may expire without renewal, leaving a vacuum that may be filled by products that are substandard or falsified.

MTaPS conducted a nine-country study in 2020 to better understand the challenges to registration of MNCH medical products in LMICs. This report presents the study’s findings both in relation to the registration status of tracer MNCH medicines and the functionality of the regulatory agencies in each country with respect to legal provisions, organization and resources, and registration processes. These findings can help with streamlining the registration of MNCH and other essential medical products and mitigating the disincentives for market entry of quality-assured MNCH products, which are, for the most part, high volume but low cost and low profit. The report presents a full set of considerations grouped around shaping the market and streamlining the registration process that can enable better access to MNCH medicines in LMICs.